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O estudo clínico NCT07221890 para Doenças Autoimunes, Artrite Reumatoide (AR), Doença inflamatória intestinal (DII), Psoriasis (PsO) está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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A Trial of Academic Detailing to Promote Prescribing of Biosimilars 1.325 Biológicos Acadêmico Virtual

Ativo, não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07221890 é um estudo intervencionista para Doenças Autoimunes, Artrite Reumatoide (AR), Doença inflamatória intestinal (DII), Psoriasis (PsO). Seu status atual é: ativo, não recrutando. O estudo começou em 6 de novembro de 2025 e pretende incluir 1.325 participantes. Coordenado por o Hospital Brigham and Women's e deve ser concluído em 31 de março de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 8 de dezembro de 2025.
Resumo
The goal of this trial is to learn if an interactive evidence-based educational outreach visits to clinicians who prescribe biologics change prescribing of biosimilar medications. The main questions it aims to answer are:

  1. Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab?
  2. Do in-person or virtual visits work better?

Researchers will compare clinicians...

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Descrição detalhada
This is a parallel, cluster randomized controlled trial in which medical practices with clinicians who prescribed adalimumab (Humira) to patients in a Humana Medicare Prescription Drug Plan (PDP) will be randomized to have eligible clinicians within the practice invited to participate in the educational module about biosimilars (the intervention group). Practices with eligible physicians that are not offered the educ...Mostrar mais
Título oficial

A Trial of Academic Detailing to Promote Prescribing of Biosimilars

Condições médicas
Doenças AutoimunesArtrite Reumatoide (AR)Doença inflamatória intestinal (DII)Psoriasis (PsO)
Outros IDs do estudo
  • 2025P002143
Número NCT
NCT07221890
Data de início (real)
2025-11-06
Última atualização postada
2025-12-08
Data de conclusão (estimada)
2027-03-31
Inscrição (estimada)
1.325
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ativo, não recrutando
Palavras-chave
biosimilar
biologic
academic detailing
clinician education
prescribing
Medicare Part D
Propósito principal
Pesquisa em serviços de saúde
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalIntervention
Offered an academic detailing session either in-person or virtually (depending on assigned geographic region), plus standard-of-care outreach from the insurance plan.
Offered an academic detailing session
Clinicians will be offered an academic detailing session that will be delivered by a specially trained pharmacist, nurse, or physician (i.e., detailer). These academic detailers will be provided and trained by an independent non-profit organization. After a clinician agrees to participate in an academic detailing session, the detailer will schedule a 1-on-1 meeting lasting 15-20 minutes during which the detailer will...Mostrar mais
Standard-of-care outreach from the insurance plan
Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars.
Comparador ativoControl
Not offered an academic detailing session. Standard-of-care outreach from the insurance plan.
Standard-of-care outreach from the insurance plan
Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Number of biosimilar adalimumab prescriptions per clinician
12 months
Number of originator adalimumab (Humira) prescriptions per clinician
12 months
Total spending (payer + patient) on adalimumab
12 months
Patient out-of-pocket spending on adalimumab
12 months
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Number of participants in the intervention arm who participated in an educational meeting with an academic detailer
6 months
Number of filled biosimilar prescriptions for other medications with biosimilar versions available, including ustekinumab, tocilizumab, and infliximab
12 months
Number of filled prescriptions for other brand-name disease-modifying medications that are FDA approved to treat 1 or more of the same indications as adalimumab, such as TNF-alpha inhibitors and interleukin inhibitors
12 months
Number of patients who fill 1 or more prescriptions for biosimilar adalimumab who subsequently switch back to originator biologic
12 months
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Criança, Adulto, Idoso
Sexos elegíveis
Todos
  • Wrote 7 or more adalimumab prescriptions that were filled by patients enrolled in research-eligible Humana Medicare Part D plans in the calendar year 2025

  • Retired
  • Not able to identify active clinical practice in the US (50 states plus Washington DC)
Brigham and Women's Hospital logoHospital Brigham and Women's
Humana Healthcare Research, Inc. logoHumana Healthcare Research, Inc.
Responsável pelo estudo
Benjamin Rome, Investigador principal, Assistant Professor of Medicine, Brigham and Women's Hospital
Sem dados de contato.
2 Locais do estudo em 1 países

Kentucky

Humana Healthcare Research, Inc., Louisville, Kentucky, 40202, United States

Massachusetts

Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States